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  1. Industry (Biologics)

Coronavirus (COVID-19) | CBER-Regulated Biologics

Collage of COVID-19 related images

CBER’s Document Control Center (DCC) will not process any submissions received by mail or courier including submissions provided on paper and electronic media (e.g., CDs, USB drives) until further notice. Submissions may be sent through the Electronic Submission Gateway or in some cases by e-mail. Please see the Letter to CBER Sponsors, Applicants and Regulated Entities.

Letter to CBER Sponsors, Applicants and Regulated Entities on COVID-19

The mission of the FDA’s Center for Biologics Evaluation and Research (CBER) is to protect and promote the public health, in part by ensuring the safety and efficacy of the products we regulate.  This includes biological products such as  prophylactic and therapeutic vaccines, whole blood and blood products, cellular products and exosomal preparations, gene therapies, tissue products and live biotherapeutic agents. CBER also regulates selected drugs and devices used in the testing and/or manufacture of our biological products. In keeping with that mission CBER uses every tool available to help patients access promising biological products while facilitating research to evaluate their safety and efficacy as well as manufacturing efforts.

CBER is working on multiple fronts to address the COVID-19 pandemic such as:

  • Expediting clinical trials for preventive vaccines and other therapeutic biological products that hold promise to prevent or treat COVID-19 by providing timely advice and interactions
  • Supporting product development and scaling up of manufacturing capacity for high priority products for COVID-19
  • Helping to ensure an adequate blood supply in light of reduced blood donations due to social distancing and the cancellation of blood drives
  • Providing information to healthcare providers and researchers to help them submit emergency IND requests to use investigational products for patients with COVID-19

If you are developing or interested in developing a CBER-regulated product to treat or prevent COVID-19, including a vaccine, cellular product, or blood-derived product, this page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance. 

CBER is making every effort to review all regulatory submissions (e.g., requests for pre-investigational new drug application (IND) meetings, INDs, and emergency use authorizations (EUAs)) for COVID-19 related treatments as quickly as possible.  In order to facilitate this rapid review, please ensure that regulatory submissions contain all of the information necessary to perform a complete review and are submitted in accordance with all regulatory requirements.

Agency review staff are prioritizing review of regulatory submissions based on a variety of factors including completeness of the submission, scientific merit, and stage of development. Although CBER is taking an all hands on deck approach to process and review regulatory submissions with the urgency warranted by this pandemic, due to the large volume of submissions and inquiries, once your product has been assigned to CBER, it may take up to one week for the appropriate review office to notify you that your submission has been received and, if applicable, rapid review has commenced.

This webpage provides additional resources to help you determine the next best steps for engaging with CBER, including what regulatory submission is appropriate, what to include in that submission, and how to submit it.

If you are not a product developer and are looking for general information on FDA and coronavirus response efforts, you can review materials provided on FDA’s COVID-19 website.  FDA has also published resources for patients about COVID-19, including Questions and Answers for Patients About Clinical Trials.

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